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短程贝伐单抗输注作为一种治疗结直肠癌的有效且安全的方法。

Short bevacizumab infusion as an effective and safe treatment for colorectal cancer.

作者信息

Taira Koichi, Okazaki Shunsuke, Akiyoshi Kohei, Machida Hirohisa, Ikeya Tetsuro, Kimura Akie, Nakata Akinobu, Nadatani Yuji, Ohminami Masaki, Fukunaga Shusei, Otani Koji, Hosomi Shuhei, Tanaka Fumio, Kamata Noriko, Nagami Yasuaki, Fujiwara Yasuhiro

机构信息

Department of Gastroenterology, Osaka Metropolitan University Graduate School of Medicine, Osaka 545-8585, Japan.

Department of Clinical Oncology, Osaka City General Hospital, Osaka 534-0021, Japan.

出版信息

Mol Clin Oncol. 2022 Jul 27;17(3):139. doi: 10.3892/mco.2022.2572. eCollection 2022 Sep.

DOI:10.3892/mco.2022.2572
PMID:35949896
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9353868/
Abstract

Bevacizumab is a humanized monoclonal antibody that contains <10% murine protein. To prevent infusion-related hypersensitivity reactions (HSRs), the initial bevacizumab infusion is delivered for 90 min, the second for 60 min and subsequent doses for 30 min. Several previous studies have shown that short bevacizumab infusions are safe and do not result in severe HSRs in patients with colorectal, lung, ovarian and brain cancer. However, the efficacy of short bevacizumab infusions for colorectal cancer management remains unclear. Therefore, to investigate this issue, a prospective multicenter study was conducted using 23 patients enrolled between June 2017 and March 2019. The initial infusion of bevacizumab was for 30 min followed by a second infusion rate of 0.5 mg/kg/min (5 mg/kg over 10 min and 7.5 mg/kg over 15 min. The primary endpoint was progression-free survival (PFS). The overall response and disease control rates were 57 and 87%, respectively. The median PFS time was 306 days (interquartile range, 204-743 days). No HSRs were noted. Adverse events associated with bevacizumab included grade 4 small intestinal perforation and grade 3 stroke in 1 patient each. These results suggest that a short bevacizumab infusion regime comprising an initial infusion for 30 min followed by a second infusion at 0.5 mg/kg/min is safe and efficacious for the management of colorectal cancer.

摘要

贝伐单抗是一种人源化单克隆抗体,含鼠蛋白<10%。为预防输注相关的超敏反应(HSR),贝伐单抗首次输注时间为90分钟,第二次为60分钟,后续剂量输注时间为30分钟。此前多项研究表明,对于结直肠癌、肺癌、卵巢癌和脑癌患者,短时间输注贝伐单抗是安全的,不会导致严重的HSR。然而,短时间输注贝伐单抗在结直肠癌治疗中的疗效仍不明确。因此,为研究此问题,开展了一项前瞻性多中心研究,纳入了2017年6月至2019年3月期间的23例患者。贝伐单抗首次输注30分钟,随后以0.5 mg/kg/分钟的速率进行第二次输注(10分钟输注5 mg/kg,15分钟输注7.5 mg/kg)。主要终点是无进展生存期(PFS)。总体缓解率和疾病控制率分别为57%和87%。PFS的中位时间为306天(四分位间距为204 - 743天)。未观察到HSR。与贝伐单抗相关的不良事件包括1例患者发生4级小肠穿孔和1例患者发生3级中风。这些结果表明,一种短时间输注贝伐单抗的方案,即首次输注30分钟,随后以0.5 mg/kg/分钟的速率进行第二次输注,在结直肠癌治疗中是安全有效的。

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Short bevacizumab infusion as an effective and safe treatment for colorectal cancer.短程贝伐单抗输注作为一种治疗结直肠癌的有效且安全的方法。
Mol Clin Oncol. 2022 Jul 27;17(3):139. doi: 10.3892/mco.2022.2572. eCollection 2022 Sep.
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Thirty-minutes infusion rate is safe enough for bevacizumab; no need for initial prolong infusion.贝伐单抗的30分钟输注速率足够安全;无需初始延长输注时间。
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Upfront FOLFOXIRI plus bevacizumab and reintroduction after progression versus mFOLFOX6 plus bevacizumab followed by FOLFIRI plus bevacizumab in the treatment of patients with metastatic colorectal cancer (TRIBE2): a multicentre, open-label, phase 3, randomised, controlled trial. upfront FOLFOXIRI 联合贝伐珠单抗和进展后再引入与 mFOLFOX6 联合贝伐珠单抗后序贯 FOLFIRI 联合贝伐珠单抗治疗转移性结直肠癌患者(TRIBE2):一项多中心、开放标签、3 期、随机、对照临床试验。
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The feasibility of a short bevacizumab infusion in patients with metastatic colorectal cancer.转移性结直肠癌患者接受短时间贝伐珠单抗输注的可行性。
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Safety of bevacizumab 7.5 mg/kg infusion over 10 minutes in NSCLC patients.贝伐珠单抗 7.5mg/kg 输注 10 分钟治疗非小细胞肺癌患者的安全性。
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本文引用的文献

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Assessment of Capecitabine and Bevacizumab With or Without Atezolizumab for the Treatment of Refractory Metastatic Colorectal Cancer: A Randomized Clinical Trial.卡培他滨和贝伐珠单抗联合或不联合阿特珠单抗治疗难治性转移性结直肠癌的评估:一项随机临床试验。
JAMA Netw Open. 2022 Feb 1;5(2):e2149040. doi: 10.1001/jamanetworkopen.2021.49040.
2
FOLFOXIRI/Bevacizumab Plus Nivolumab as First-Line Treatment in Metastatic Colorectal Cancer RAS/BRAF Mutated: Safety Run-In of Phase II NIVACOR Trial.FOLFOXIRI/贝伐单抗联合纳武单抗作为RAS/BRAF突变转移性结直肠癌的一线治疗:II期NIVACOR试验的安全性导入期
Front Oncol. 2021 Dec 14;11:766500. doi: 10.3389/fonc.2021.766500. eCollection 2021.
3
AtezoTRIBE: a randomised phase II study of FOLFOXIRI plus bevacizumab alone or in combination with atezolizumab as initial therapy for patients with unresectable metastatic colorectal cancer.
AtezoTRIBE:FOLFOXIRI 联合贝伐珠单抗单药或联合阿替利珠单抗作为不可切除转移性结直肠癌初始治疗的随机 II 期研究。
BMC Cancer. 2020 Jul 22;20(1):683. doi: 10.1186/s12885-020-07169-6.
4
Clinical activity and molecular correlates of response to atezolizumab alone or in combination with bevacizumab versus sunitinib in renal cell carcinoma.阿替利珠单抗单药或联合贝伐珠单抗与舒尼替尼治疗肾细胞癌的临床活性和分子相关性。
Nat Med. 2018 Jun;24(6):749-757. doi: 10.1038/s41591-018-0053-3. Epub 2018 Jun 4.
5
Atezolizumab for First-Line Treatment of Metastatic Nonsquamous NSCLC.阿替利珠单抗作为转移性非鳞状 NSCLC 一线治疗药物。
N Engl J Med. 2018 Jun 14;378(24):2288-2301. doi: 10.1056/NEJMoa1716948. Epub 2018 Jun 4.
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Association of Primary Tumor Site With Mortality in Patients Receiving Bevacizumab and Cetuximab for Metastatic Colorectal Cancer.贝伐珠单抗联合西妥昔单抗治疗转移性结直肠癌患者的原发肿瘤部位与死亡率的关系。
JAMA Surg. 2018 Jan 1;153(1):60-67. doi: 10.1001/jamasurg.2017.3466.
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Randomized phase III study of bevacizumab plus FOLFIRI and bevacizumab plus mFOLFOX6 as first-line treatment for patients with metastatic colorectal cancer (WJOG4407G).贝伐珠单抗联合 FOLFIRI 和贝伐珠单抗联合 mFOLFOX6 作为转移性结直肠癌一线治疗的随机 III 期研究(WJOG4407G)。
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J BUON. 2015 May-Jun;20(3):923-7.
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Med Oncol. 2014 Nov;31(11):276. doi: 10.1007/s12032-014-0276-1. Epub 2014 Oct 8.
10
The feasibility of a short bevacizumab infusion in patients with metastatic colorectal cancer.转移性结直肠癌患者接受短时间贝伐珠单抗输注的可行性。
Anticancer Res. 2014 Feb;34(2):1053-6.